Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204237
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-03
Brief Title:
Safety Tolerability and Biodistribution of 89ZrZr-DFO-APAC in Subjects with PAODCLI and Healthy Volunteers Acronyms 89Zr Zirconium-89 DFO Desferrioxamine APAC AntiPlatelet AntiCoagulant PETCT Positron Emission TomographyComputed Tomography
Sponsor:
Aplagon Oy
Organization:
Aplagon Oy
Study Overview
Official Title:
Safety Tolerability and Biodistribution of 89ZrZr-DFO-APAC Phase 0 in Subjects with Peripheral Arterial Occlusive Disease Critical Limb Ischemia PAODCLI and Healthy Volunteers - an Open Label PET Study Acronyms 89Zr Zirconium-89 DFO Desferrioxamine APAC AntiPlatelet AntiCoagulant PETCT Positron Emission TomographyComputed Tomography
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHASE
Brief Summary:
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of 89ZrZr-DFO-APAC in patients with peripheral arterial occlusive disease critical limb ischemia PAODCLI and healthy volunteers The main questions it aims to answer are
What is the safety tolerability and pharmacokinetic profile PK both systemic and local vascular injury site-specific PK of 89ZrZr-DFO-APAC
What is the biodistribution and internal radiation dosimetry of the tracer dose of 89ZrZr-DFO-APAC
What is the binding and retention time of 89ZrZr-DFO-APAC to arteries and atherosclerotic or microvascular lesions Participants will receive a dose of the 89ZrZr-DFO-APAC IMP and PETCT imaging is performed on days 1 3 and 7 and follow-up visit 7-14 days post IMP dosing
What is the safety tolerability and pharmacokinetic profile PK both systemic and local vascular injury site-specific PK of 89ZrZr-DFO-APAC
What is the biodistribution and internal radiation dosimetry of the tracer dose of 89ZrZr-DFO-APAC
What is the binding and retention time of 89ZrZr-DFO-APAC to arteries and atherosclerotic or microvascular lesions Participants will receive a dose of the 89ZrZr-DFO-APAC IMP and PETCT imaging is performed on days 1 3 and 7 and follow-up visit 7-14 days post IMP dosing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17489 | REGISTRY | UMCG PaNaMa registry | None |